Enhanced Controlled Steering Functionality for Implant-Delivery Tools
Legal Citation
Summary of the Inventive Concept
The inventive concept relates to a system and method for delivering an implant to a heart of a patient using a steerable delivery tool with improved controlled steering functionality, enabling more precise and efficient implant delivery.
Background and Problem Solved
The original patent disclosed a controlled steering functionality for an implant-delivery tool, which, although effective, had limitations in terms of precision and efficiency. The new inventive concept addresses these limitations by introducing a coupling mechanism, control unit, and sensor to enable axial advancement and rotational orientation of the second catheter relative to the first catheter, providing real-time feedback to the user.
Detailed Description of the Inventive Concept
The system comprises a first catheter with a steerable distal end portion and a second catheter with a steerable distal end portion, configured for advancement through a lumen of the first catheter. A coupling mechanism enables axial advancement and rotational orientation of the second catheter relative to the first catheter. A control unit, comprising a motor and gearbox, provides precise control over the axial advancement and rotational orientation of the second catheter. A sensor detects the position and orientation of the second catheter relative to the first catheter, providing real-time feedback to the user during the delivery of the implant. The method involves providing the first and second catheters, axially advancing and rotationally orienting the second catheter using the coupling mechanism and control unit, and delivering the implant to the heart of the patient.
Novelty and Inventive Step
The new inventive concept introduces a coupling mechanism, control unit, and sensor, which are not present in the original patent. These components enable precise control over the axial advancement and rotational orientation of the second catheter, providing real-time feedback to the user, which is not achievable with the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include different types of coupling mechanisms, control units, and sensors. For example, the coupling mechanism could be a magnetic or mechanical coupling, and the control unit could be a manual or automated system. The sensor could be an optical, electromagnetic, or ultrasonic sensor.
Potential Commercial Applications and Market
The inventive concept has potential commercial applications in the field of cardiac valve repair, enabling more precise and efficient implant delivery. The target market includes medical device companies, hospitals, and clinics specializing in cardiac surgery.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61F2/2427 |
| A | A61 | A61B17/068 |
| A | A61 | A61B17/105 |
| A | A61 | A61F2/2445 |
| A | A61 | A61F2/2466 |
| A | A61 | A61M25/0054 |
| A | A61 | A61M25/0068 |
| A | A61 | A61M25/01 |
| A | A61 | A61M25/0105 |
| A | A61 | A61M25/0108 |
| A | A61 | A61M25/0136 |
| A | A61 | A61M25/0147 |
| A | A61 | A61M25/0662 |
| A | A61 | A61B2017/00305 |
| A | A61 | A61B2017/00314 |
| A | A61 | A61B2017/00323 |
| A | A61 | A61B2017/00367 |
| A | A61 | A61B2017/0649 |
| A | A61 | A61B2017/293 |
| A | A61 | A61B2090/0811 |
| A | A61 | A61F2210/0014 |
| A | A61 | A61F2250/001 |
| A | A61 | A61F2250/0098 |
| A | A61 | A61M25/005 |
| A | A61 | A61M25/0133 |
| A | A61 | A61M2025/0004 |
| A | A61 | A61M2025/0006 |
| A | A61 | A61M2025/015 |
| A | A61 | A61M2025/0681 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical device engineering, specifically interventional cardiology and catheter-based implant delivery systems, involving advanced medical device design, steerable catheter mechanisms, and minimally invasive surgical technologies
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device designer with expertise in catheter design, mechanical engineering, and interventional cardiology techniques, possessing advanced degrees and 5-10 years of experience in developing steerable medical devices
Obviousness Rationale
A person having ordinary skill in the art would recognize that the published technical disclosure represents predictable variations and incremental improvements to the existing steerable catheter technology disclosed in the source patent. The additional components like the coupling mechanism, control unit, and sensor represent logical extensions of known medical device engineering principles applied to enhance precision and controllability of implant delivery systems. These modifications would be considered obvious combinations of known techniques to achieve improved functional outcomes in interventional medical procedures.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,415 |
|---|---|
| Title | Controlled steering functionality for implant-delivery tool |
| Assignee(s) | Edwards Lifesciences Innovation (Israel) Ltd. |